A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
This study aims to discover more about the long-term safety and effectiveness of a drug called litifilimab for adults with lupus that mainly affects their skin (cutaneous lupus erythematosus). It focuses on people with specific types of chronic or subacute cutaneous lupus, or both, who might also have systemic lupus erythematosus (SLE). Participants must have previously taken part in an earlier study for litifilimab and found that standard treatments like antimalarials didn't work for them or caused too many problems. Researchers will closely monitor for any side effects and see how the drug helps with skin symptoms and overall quality of life over a long period, up to 5 years in some cases.
At a glance
What is this study about?
This study is designed to help us learn more about a new medicine called litifilimab (also known as BIIB059). This medicine is being tested for people who have specific types of lupus that affect the skin. These conditions are called subacute cutaneous lupus erythematosus and chronic cutaneous lupus erythematosus. Some people in the study might also have systemic lupus erythematosus (SLE), which is a broader form of lupus.
You might be interested in this study if you have one of these types of lupus, and your current treatments, like antimalarial medicines, haven't worked well for you or have caused unpleasant side effects. The main purpose of this study is to understand how safe litifilimab is over a longer period. Researchers will be carefully watching for any unwanted health problems that might happen while people are taking the drug.
Beyond safety, the study also wants to see if litifilimab helps to improve the symptoms of skin lupus. They will use different ways to measure how your skin is affected and how your daily life and well-being are impacted. This information is important because it could help doctors in the future make better decisions about treating people with these challenging skin conditions.
Key takeaways
- This study is for adults with specific types of skin lupus who completed a previous trial.
- It aims to learn about the long-term safety and effectiveness of litifilimab.
- Litifilimab is given as an injection under the skin every 4 weeks.
- The study measures skin symptoms, quality of life, and watches for side effects.
- Participation involves regular clinic visits for up to 2 or 5 years, depending on location.
Who may be eligible?
This study is for adults who have already taken part in a previous litifilimab study (called 230LE301) and completed it properly. This means you would have received the study medicine for a certain amount of time and attended all your final appointments.
To join, you must also be able to understand what the study involves, including any potential benefits and risks, and agree to take part by signing a consent form. You also need to be willing to allow your health information to be used for research purposes.
You won't be able to join if you stopped the previous study early or didn't complete all the required visits. Also, if the study doctor thinks you have developed any new health problems that would make it unsafe for you to be in the study, you won't be able to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Did you complete the earlier litifilimab study (230LE301)?
- Are you 18 years old or over?
- Do you understand what the study involves and agree to take part?
- Do you have a type of lupus that affects your skin (cutaneous lupus erythematosus)?
What does participation involve?
If you join this study, your first visit will be directly after your last visit for the previous study you were in. You will receive the study drug, litifilimab, as an injection under your skin typically every 4 weeks. Both you and the study team will know that you are receiving the active drug and what the dose is.
The treatment period will last for quite a while – up to 2 years for most people, but for those in the United States, it could be up to 5 years. After the treatment period, there will be a follow-up safety period of up to 24 weeks. Throughout the study, you'll have regular visits to the clinic to check on your health, monitor your lupus symptoms, and discuss any side effects. Depending on where you live, you could have up to 27 visits over 2 years, or up to 66 visits over 5 years if you're in the US.
Potential risks and benefits
Locations (104)
- University of Alabama at Birmingham - (UAB)Verified postcodeBirmingham, United States
- Arizona Arthritis & Rheumatology Research, PLLCVerified postcodePhoenix, United States
- Dermatology Research AssociatesVerified postcodeLos Angeles, United States
- Inland Rheumatology Clinical Trials, Inc.Verified postcodeUpland, United States
- David Fivenson, MD, Dermatology, PLLCVerified postcodeAnn Arbor, United States
- Revival Research Institute, LLCVerified postcodeTroy, United States
- Saint Louis UniversityVerified postcodeSt Louis, United States
- Thurston Arthritis Research CenterVerified postcodeChapel Hill, United States
- Duke Dermatology South DurhamVerified postcodeDurham, United States
- University of Cincinnati Health Physicians Office DermatologyVerified postcodeCincinnati, United States
- University of PennsylvaniaVerified postcodePhiladelphia, United States
- UT Southwestern Medical CenterVerified postcodeDallas, United States
Common questions
What is lupus that affects the skin?
Lupus is a condition where your immune system mistakenly attacks healthy tissues. When it mainly affects your skin, it causes rashes, sores, or lesions, particularly on sun-exposed areas.
What is litifilimab?
Litifilimab is a new medicine being tested to see if it can help improve symptoms in people with lupus affecting the skin. It's given as an injection.
Will I know if I'm getting the real medicine?
Yes, in this study, everyone will receive litifilimab, and both you and the study team will know you are getting the active medicine.
How long will I be in the study?
The study could last up to 2 years, or potentially up to 5 years if you're in the United States, including a period where your health is monitored after treatment.
What does 'adverse events' mean?
Adverse events are any unwanted health problems that happen during the study. They might or might not be caused by the study medicine.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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